RABEPRAZOLE SODIUM- rabeprazole sodium tablet, delayed release 
Lupin Pharmaceuticals, Inc.

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MEDICATION GUIDE

Rabeprazole Sodium (ra bep′ ra zole soe′ dee um)

Delayed-Release Tablets

Rx Only

Read the Medication Guide that comes with rabeprazole sodium delayed-release tablets before you start taking it and each time you get a refill. There may be new information. This Medication Guide does not take the place of talking to your doctor about your medical condition or treatment.

What is the most important information I should know about rabeprazole sodium delayed-release tablets?

Rabeprazole sodium delayed-release tablets may help your acid-related symptoms, but you could still have serious stomach problems. Talk with your doctor.

Rabeprazole sodium delayed-release tablets can cause serious side effects, including:

Talk to your doctor about your risk of these serious side effects if you take rabeprazole sodium delayed-release tablets.

Rabeprazole sodium delayed-release tablet can have other serious side effects. See "What are the possible side effects of rabeprazole sodium delayed-release tablets?"

What are rabeprazole sodium delayed-release tablets?

Rabeprazole sodium delayed-release tablet is a prescription medicine called a proton pump inhibitor (PPI).

Rabeprazole sodium delayed-release tablet reduces the amount of acid in your stomach.

Rabeprazole sodium delayed-release tablets are used in adults:

Rabeprazole sodium delayed-release tablet is used in adolescents 12 years of age and older to treat symptoms of Gastroesophageal Reflux Disease (GERD) for up to 8 weeks.

It is not known if rabeprazole sodium delayed-release tablet is safe and effective in children to:

Rabeprazole sodium delayed-release tablets should not be used in children under 12 years of age.

Who should not take rabeprazole sodium delayed-release tablets?

Do not take rabeprazole sodium delayed-release tablets if you:

What should I tell my doctor before taking rabeprazole sodium delayed-release tablets?

Before you take rabeprazole sodium delayed-release tablets tell your doctor if you:

Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Rabeprazole sodium delayed-release tablet may affect how other medicines work, and other medicines may affect how rabeprazole sodium delayed-release tablet works. Especially tell your doctor if you take an antibiotic that contains clarithromycin or amoxicillin or if you take warfarin (COUMADIN, JANTOVEN) or methotrexate (Otrexup, Rasuvo, Trexall). Know the medicines that you take. Keep a list of them to show your doctor and pharmacist when you get a new medicine.

How should I take rabeprazole sodium delayed-release tablets?

What are the possible side effects of rabeprazole sodium delayed-release tablets?

Rabeprazole sodium delayed-release tablets may cause serious side effects, including:

Tell your doctor right away and get medical care if you have any of these symptoms:

Your doctor may check the level of magnesium in your body before you start taking rabeprazole sodium delayed-release tablets, during treatment, or if you will be taking rabeprazole sodium delayed-release tablets for a long period of time.

The most common side effects of rabeprazole sodium delayed-release tablets in adults include:

The most common side effects of rabeprazole sodium delayed-release tablets in adolescents 12 years of age and older include:

Other side effects:

Serious allergic reactions. Tell your doctor if you get any of the following symptoms with rabeprazole sodium delayed-release tablets:

Your doctor may stop rabeprazole sodium delayed-release tablets if these symptoms happen.

These are not all of the possible side effects of rabeprazole sodium delayed-release tablets. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

How should I store rabeprazole sodium delayed-release tablets?

Keep rabeprazole sodium delayed-release tablets and all medicines out of the reach of children.

General Information about rabeprazole sodium delayed-release tablets

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use rabeprazole sodium delayed-release tablets for a condition for which it was not prescribed. Do not give rabeprazole sodium delayed-release tablets to other people, even if they have the same symptoms that you have. It may harm them.

You can ask your doctor or pharmacist for information about rabeprazole sodium delayed-release tablets that is written for health professionals.

What are the ingredients in rabeprazole sodium delayed-release tablets?

Active ingredient: rabeprazole sodium

Inactive ingredients: black iron oxide, carnauba wax, crospovidone, diacetylated monoglycerides, ethyl cellulose, hydroxypropyl cellulose, hypromellose phthalate, lecithin, light magnesium oxide, magnesium stearate, mannitol, polyethylene glycol, polyvinyl alcohol, shellac, sodium stearyl fumarate, talc, titanium dioxide and yellow iron oxide.

The brands listed are trademarks of their respective owners and are not trademarks of Lupin Pharmaceuticals, Inc. The makers of these brands are not affiliated with and do not endorse Lupin Pharmaceuticals, Inc. or its products.

For more information, go to www.lupinpharmaceuticals.com or call the toll free number 1-800-399-2561.

This Medication Guide has been approved by the U.S. Food and Drug Administration.

Manufactured for:

Lupin Pharmaceuticals, Inc.

Baltimore, Maryland 21202

United States

Manufactured by:

Lupin Limited

Goa 403722

INDIA

Revised: November 25, 2016                                                                                        ID#: 249582

Revised: 11/2016
Lupin Pharmaceuticals, Inc.